| CTRI Number |
CTRI/2025/07/090865 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Postoperative Kidney Dysfunction After Major Lung Resection : A Retrospective Analysis |
|
Scientific Title of Study
|
Postoperative Kidney Dysfunction After Major Lung Resection : A Retrospective Analysis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyotirmoy Das |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Department of Anesthesiology and Critical Care Medanta The Medicity Sector 38 Gurgaon Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
9899572049 |
| Fax |
|
| Email |
reachjyotirmoy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotirmoy Das |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Department of Anesthesiology and Critical Care Medanta The Medicity Sector 38 Gurgaon Haryana
HARYANA
122001
India |
| Phone |
9899572049 |
| Fax |
|
| Email |
reachjyotirmoy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotirmoy Das |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Department of Anesthesiology and Critical Care Medanta The Medicity Sector 38 Gurgaon Haryana
HARYANA
122001
India |
| Phone |
9899572049 |
| Fax |
|
| Email |
reachjyotirmoy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medanta The Medicity |
| Address |
Ch Bhaktawar Singh Road Sector 38 Gurgaon Haryana India 122001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Agrawal |
Medanta The Medicity |
Department of Anesthesiology and Critical Care Medanta The Medicity Ch Bhaktawar Singh Raod Sector 38 Gurgaon 122001 Haryana India
Gurgaon
HARYANA |
9098566720
nidhiagrawal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients who underwent major lung resections (lobectomy, bilobectomy, pneumonectomy).
Complete preoperative and postoperative renal function data available.
|
|
| ExclusionCriteria |
| Details |
Patients with pre-existing severe renal impairment (chronic kidney disease )
Incomplete perioperative data or lost to follow-up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of acute kidney injury (AKI) in patients undergoing major lung resection surgeries (lobectomy, bilobectomy, and pneumonectomy), utilizing the Acute Kidney Injury Network (AKIN) criteria . |
Preop, post op 0,1,2,3,7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the demographic, clinical, & perioperative factors associated with the development of AKI, including Age, gender, BMI, & comorbidities (e.g., hypertension, diabetes). Surgical characteristics such as type of surgery, duration, intraoperative blood loss, & fluid management. |
At baseline |
To perform subgroup analyses based on:
Surgical Type: Comparing AKI incidence & outcomes between lobectomy, bilobectomy, & pneumonectomy.
Pathology: Comparing malignant (e.g., lung cancer) vs. non-malignant (e.g., post-tubercular sequelae) cases.
|
POD 7 & baseline |
To evaluate the impact of AKI on postoperative outcomes, including:
Length of ICU stay.
Total hospital stay duration.
Need for renal replacement therapy (RRT).
Mortality within the postoperative period.
|
Baseline till day of discharge |
To compare the findings with existing literature to investigate the results within global thoracic surgery outcomes.
|
Baseline & postoperative analysis |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This retrospective observational study at Medanta – The Medicity aims to evaluate the incidence of acute kidney injury (AKI) in patients undergoing major lung resections. It will analyze risk factors, surgical characteristics, and the impact of AKI on postoperative outcomes, using data from surgeries performed between January 2023 and December 2024. |